Clearance Summary
INION HEXALON BIODEGRADABLE ACL/PCL SCREW received FDA 510(k) clearance under submission number K060393, sponsored by Inion , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-03-13.
- Submission: K060393
- Applicant / Sponsor: Inion , Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2006-03-13
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.